Evolocumab in Patients With Multivessel Coronary Disease After Acute Myocardial Infarction: A Target Trial Emulation (EVEREST)

Fudan University

Status: Completed

Conditions: Multivessel Coronary Artery Disease; Acute Myocardial Infarction (AMI)

Treatments: Drug: Lipid Lowering Medication; Drug: Evolocumab

Study type: Observational

Funder types: Other

Identifiers

NCT06740552

SHDC2024CRI050

Details and patient eligibility

About

The goal of this Target Trial Emulation (TTE) study is to evaluate the effect of evolocumab on clinical prognosis in patients with multivessel disease (MVD) following acute myocardial infarction (AMI) who have deferred non-culprit vessel. The main question it aims to answer is:

Does evolocumab lower risks of major adverse cardiovascular events (MACE) in patients with deferred non-culprit vessel after AMI?

Full description

This study aims to investigate the potential prognostic benefits of evolocumab in patients with MVD after AMI at 2-year follow-up. The primary endpoint is MACE, defined as a composite of cardiac death, myocardial infarction, stroke, angina-driven coronary revascularization, and rehospitalization for heart failure. This is a multicentre, cohort-based TTE study and the target RCT is the FOURIER trial.

Enrollment: 1,862 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years old;
• Acute myocardial infarction diagnosed at hospital admission;
• Multivessel coronary artery disease diagnosed at primary invasive coronary angiography;
• Culprit vessel successfully revascularized;
• At lease 1 non-culprit vessel with ≥50% stenosis and deferred at the opinion of the operator, and no staged revascularization within 6 months.

Exclusion criteria

• Cardiac shock, hemodynamically unstable, or severe heart failure (Killip IV)
• Any cardiac surgery within 6 weeks prior to screening;
• Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m^2 at screening;
• Contraindication or allergy to iodinated contrast agent;
• Malignancy except non-melanoma skin cancers, cervical, or breast ductal carcinoma in situ within the last 5 years;
• Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed in short term.

Trial design

1,862 participants in 1 patient group

TTE cohort

Description:

The TTE cohort is the finally anlyzed population. The participates are enrolled upon meeting the inclusion/exclusion criteria.

Treatment:

Drug: Evolocumab

Drug: Lipid Lowering Medication